Who is sponsoring NCT03691051?

NCT03691051 is sponsored by Henan Cancer Hospital.

What drugs are being tested in NCT03691051?

Interventions in NCT03691051: Pyrotinib plus Capecitabine.

What condition does NCT03691051 study?

NCT03691051 studies HER2 Positive Metastatic Breast Cancer.

Is NCT03691051 still recruiting?

NCT03691051 is currently status unknown. Last updated 25 September 2023.

Last reviewed 2023-09-25 · How we verify

NCT03691051

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

Status unknown Phase 2 Last updated 25 September 2023

What this trial tests

Phase 2 trial testing Pyrotinib plus Capecitabine in HER2 Positive Metastatic Breast Cancer in 78 participants. Status unknown.

Timeline

20 November 2018

Primary endpoint
16 April 2021

30 December 2024

Quick facts

Lead sponsor	Henan Cancer Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	78
Start date	20 November 2018
Primary completion	16 April 2021
Estimated completion	30 December 2024
Sites	1 location across China

Drugs / interventions tested

Pyrotinib plus Capecitabine — full drug profile →

Conditions studied

HER2 Positive Metastatic Breast Cancer — all drugs for HER2 Positive Metastatic Breast Cancer →

Sponsor

Henan Cancer Hospital

Who can join

18 and older, any sex, with HER2 Positive Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study of pyrotinib plus capecitabine as the Therapy of brain metastases from HER2-positive metastatic breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment strategies for breast cancer brain metastases.
Bailleux C, Eberst L, Bachelot T. · · 2021 · cited 170× · PMID 33250512 · DOI 10.1038/s41416-020-01175-y
Pyrotinib plus capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases (PERMEATE): a multicentre, single-arm, two-cohort, phase 2 trial.
Yan M, Ouyang Q, Sun T, Niu L, et al · · 2022 · cited 123× · PMID 35085506 · DOI 10.1016/s1470-2045(21)00716-6
Mechanism, safety and efficacy of three tyrosine kinase inhibitors lapatinib, neratinib and pyrotinib in HER2-positive breast cancer.
Xuhong JC, Qi XW, Zhang Y, Jiang J. · · 2019 · cited 118× · PMID 31720077
Breast cancer brain metastasis: Current evidence and future directions.
Sun H, Xu J, Dai S, Ma Y, et al · · 2023 · cited 46× · PMID 35822637 · DOI 10.1002/cam4.5021
Evolving treatment strategies of brain metastases from breast cancer: current status and future direction.
Kim JS, Kim IA. · · 2020 · cited 32× · PMID 32636942 · DOI 10.1177/1758835920936117
New Therapeutics in HER2-Positive Advanced Breast Cancer: Towards a Change in Clinical Practices?pi.
Mezni E, Vicier C, Guerin M, Sabatier R, et al · · 2020 · cited 22× · PMID 32545895 · DOI 10.3390/cancers12061573
Management of Brain and Leptomeningeal Metastases from Breast Cancer.
Pellerino A, Internò V, Mo F, Franchino F, et al · · 2020 · cited 19× · PMID 33198331 · DOI 10.3390/ijms21228534
Local and systemic treatment for HER2-positive breast cancer with brain metastases: a comprehensive review.
Chan WL, Lam TC, Lam KO, Luk MY, et al · · 2020 · cited 14× · PMID 32973930 · DOI 10.1177/1758835920953729

Verify or expand the search:

Other Henan Cancer Hospital trials

Trials by the same sponsor.

NCT07442890 — A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Ro · NA · not yet recruiting
NCT07472621 — Real-World Effectiveness and Safety of Glofitamab in Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma · not yet recruiting
NCT07459608 — Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma · Phase 2 · not yet recruiting
NCT07400575 — Anlotinib in Cross-line Treatment of NSCLC and SCLC · not yet recruiting
NCT07332221 — Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03691051 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Henan Cancer Hospital
Last refreshed: 25 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03691051.

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